BioDuro-Sundia
Integrated discovery-to-IND platform with 30 years of CRDMO expertise in chemistry, biology, and manufacturing.
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Integrated CRDMO with 30 years of expertise spanning discovery chemistry, biology, DMPK, and IND-enabling development for small and large molecules, plus API and drug product manufacturing. Headquartered in Irvine, United States.
Phases
Indications / Therapeutic Areas
Services
- Discovery Research
- Target Identification & Validation
- High-Throughput Screening
- Computational & In-Silico Drug Discovery
- Medicinal Chemistry
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- Safety Pharmacology
- Genetic Toxicology
- Preclinical In Vitro Studies
- In Vivo Efficacy Models
- In Vivo PK / PD Studies
- GLP Toxicology
- Specialized & Large-Animal Models
- Preclinical In Vivo Studies
- Bioanalysis
- Biomarker Assays
- Flow Cytometry Services
- Analytical Method Development & Validation
- ICH Stability Studies
- Translational Research
- US FDA Regulatory Strategy
- China NMPA Regulatory Strategy
- Regulatory Affairs
Modalities
Technical specifications & accreditations
Accreditations
Infrastructure
About this organization
Overview
BioDuro-Sundia is a contract research, development, and manufacturing organization (CRDMO) with over 28–30 years of proven track record. An Advent International portfolio company headquartered in Irvine, California, BioDuro employs more than 2,000 scientists.
Core Capabilities
Discovery & Development Services:
- Integrated discovery chemistry, biology, and drug metabolism and pharmacokinetics (DMPK)
- Small-molecule drug discovery with high-throughput screening across billions of compounds
- Medicinal chemistry and computational approaches
- Pharmacology and in vitro evaluation platforms
IND-Enabling & Manufacturing:
- Comprehensive IND-enabling capabilities including GLP toxicology studies and bioanalytical services
- Drug substance (API) and drug product development
- Bioavailability enhancement and custom release formulations (delayed, sustained)
- Manufacturing support through PCC (pre-clinical candidate) stage
Specialized Preclinical Models:
- Advanced preclinical disease models, including NASH (non-alcoholic steatohepatitis)
- In vivo efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies
- Safety pharmacology and genetic toxicology
Strategic Partnerships: BioDuro has established a strategic partnership with CTI Biotechnology to strengthen GLP toxicology and bioanalytical capabilities, enabling a fully integrated discovery-to-IND platform.
Regulatory & Market Reach
The organization supports IND filing across global markets and has demonstrated success in advancing programs toward clinical development.
Locations
Headquarters
Irvine · California · United States
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